Tip part for forming a tip of a disposable insertion endoscope

This application is a National Stage entry filed under 35 U.S.C. § 371 of International Application No. PCT/EP2020/083527, filed Nov. 26, 2020, which claims priority from and the benefit of European Patent Application No. EP20153967.3, filed Jan. 28, 2020; the contents of the aforementioned applications are incorporated herein by reference in their entirety.

The present disclosure relates to insertable medical vision devices, such as, but not limited to, endotracheal tubes and endoscopes, in particular disposable insertion endoscopes, more specifically to a tip part of such a vision device, to an endoscope with such a tip part, and to a method of manufacture of such a tip part.

Vision devices, such as endoscopes, are well known for visually inspecting inaccessible places such as human body cavities. Typically, the endoscope comprises an elongated insertion tube with a handle at the proximal end, as seen from the operator, and visual inspection means, such as a built-in camera including a vision sensor, at a distal end of the elongated insertion tube. This definition of the terms distal and proximal, i.e. “proximal” being the end closest to the operator and “distal” being the end remote from the operator, as used herein for endoscopes in general, is adhered to in the present specification. Electrical wiring for the camera and other electronics, such as one or more LEDs accommodated in the tip part at the distal end, runs along the inside of the elongated insertion tube from the handle of the endoscope to the tip part. A working or suction channel may run along the inside of the insertion tube from the handle to the tip part, e.g. allowing liquid to be removed from the body cavity or allowing for insertion of surgical instruments or the like into the body cavity. The suction channel may be connected to a suction connector, typically positioned at a handle at the proximal end of the insertion tube.

To be able to manoeuvre the endoscope inside the body cavity, the distal end of the endoscope may comprise a bending section with increased flexibility, e.g. a number of articulated segments of which the tip part or an external housing thereof may form the distalmost segment. The manoeuvring of the endoscope inside the body is typically done by tensioning or slacking pull wires also running along the inside of the elongated insertion tube from the tip part through the remainder of articulated segments to a control mechanism of the handle.

As the name indicates, endoscopes are used for seeing inside things, such as lungs or other human body cavities of a patient. Modern endoscopes are therefore typically equipped with a light source and a camera or vision receptor including a vision or image sensor. Provided that sufficient light is present, it is possible for the operator to see where the endoscope is steered and to set the target of interest once the tip has been advanced thereto. This therefore normally requires illumination of the area in front of the distal tip of the endoscope, in particular the field of vision of the camera(s). The light source, such as a light emitting diode or an optical fiber, may provide illumination.

Additionally, when, as in the present disclosure, the insertion tube of the endoscope is intended to be inserted into a human body cavity, the insertion tube should furthermore be sealed in a watertight manner. This is particularly the case for a distal tip part accommodating a camera, LED(s), and/or other delicate electronics, prone to malfunction or destruction if exposed to humidity.

One known way of sealing the tip part of an endoscope is disclosed in WO2010/066790. In this document, a transparent monolithic housing is formed around the electronics and working channel by placing the electronics and the tube forming the working channel in a mold of transparent material, such as silicone. A transparent UV curable resin is then inserted from the bottom of the mold to avoid bubbles to form in the transparent resin. Because the resin rises slowly from the bottom, the air is slowly expelled from top of the mold, without any risk of air bubbles being trapped in the mold. The resin is then cured using UV irradiation through the transparent mold to form the monolithic housing.

A first aspect of this disclosure relates to a tip part for forming a tip of a disposable insertion endoscope, the tip part comprising:

The abutment surface may circumscribe the fluid opening. The abutment surface may be annular. A width of the abutment surface may be an extent the abutment surface extends from the tube sleeve wall to the fluid opening. A width of the abutment surface may extend from an interior surface of the tube sleeve wall to the fluid opening. The width may extend radially from the interior surface of the tube sleeve wall to the fluid opening. the width may extend substantially perpendicularly to the length of the tube sleeve wall. A width of the abutment surface may be measured radially from an interior surface of the tube sleeve wall and to the fluid opening. The width of the abutment surface may be equal to or less than 1/30, 1/29, 1/28, 1/27, 1/26, 1/25, 1/24, 1/23, 1/22, 1/21, 1/20, 1/19, 1/18, 1/17, 1/16, 1/15, 1/14, 1/13, 1/12, 1/11, 1/10, 1/9, ⅛, 1/7, ⅙, ⅕, ¼, ⅓, ½, ⅖, ⅗, ⅔, ⅘, or 9/10 of the total tube sleeve length S. The width of the abutment surface may be equal to or less than a thickness of an inserted tube. The width may be equal to or greater than a thickness of an inserted tube. The width of the abutment surface may be equal to or less than a thickness of the tube sleeve wall. The width of the abutment surface may be equal to or greater than a thickness of the tube sleeve wall. The width of the abutment surface may be equal to or less than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, or 0.5 times a thickness of the tube sleeve wall.

The tube insertion sleeve may be formed integrally and in one piece with the exterior housing.

The circumferential tube sleeve wall may be at least partly formed by the circumferential housing wall. Alternatively, the circumferential tube sleeve wall may be formed separately of the circumferential housing wall i.e. not integrally or in one piece with the circumferential housing wall.

The tip part may comprise at least two, three, four, five, six or more tube insertion sleeves provided in the interior spacing. Each tube insertion sleeve may be formed by a circumferential tube sleeve wall. At least two, potentially at least three, of the tube insertion sleeves may be at least partly formed by a common circumferential tube sleeve wall. The circumferential tube sleeve wall of at least one tube insertion sleeve may be at least partly formed by the circumferential housing wall and at least partly by a circumferential tube sleeve wall of an adjacent tube insertion sleeve. Each tube insertion sleeve may be at least partly formed by a circumferential tube sleeve wall of an adjacent circumferential tube sleeve wall. One or more circumferential tube sleeve walls may be formed separately of the circumferential housing wall i.e. not integrally or in one piece with the circumferential housing wall.

This may have the advantage of reducing the footprint and thereby the required space for each tube insertion sleeve whereby the cross-sectional extent and/or diameter of exterior housing may be reduced.

At least a part of two tube insertion sleeves extending side-by-side may include an open slot extending longitudinally between them.

The open slot may allow for the two tubes to be positioned close to, potentially abutting, each other along a longitudinal direction when the tubes are positioned in the tube insertion sleeves.

Potentially, parts of the fluid channels along a longitudinal direction may be coinciding and/or parts of circumferential walls may be removed from the cut-outs where the fluid channels intersect each other.

Accordingly, outlets from two tubes and/or open proximal ends of two tube insertion sleeves may be shaped like the number “8”, especially if the tubes have a rounded or circular cross-section.

This embodiment may make it possible to minimize dimensions of the tube insertion sleeves and/or tubes since they are positioned very close to each other. This may, in turn, allow for a reduction of a total cross-sectional or radial extent of the tip part and/or the exterior housing.

This embodiment may also make it possible or at least easier to mold the tube insertion sleeves since there is a connection between them.

The tube, which may alternatively be denoted a pipe, may be a working channel tube, fluid supply tube, fluid suction tube, or the like.

A tube may be positioned in each tube insertion sleeve. Each tube may extend through the tip part, potentially to a respective fluid source. Each tube may be provided separately from or not in one piece with the exterior housing. The tubes may be for gas, a second of the tubes may be for liquid.

In the context of the present disclosure, a tube is any component which allows tight fluid flow through it and which has a length above zero.

Positioning of tubes in the tube insertion sleeves may occur subsequent to manufacture of the exterior housing including tube insertion sleeve and potentially the camera window and/or the camera insertion sleeve. The one or more tubes may be inserted into the tube insertion sleeves in a proximal to distal direction, potentially through a proximally positioned opening of the exterior housing.

An outer diameter or largest outer cross-section of an outer surface of each tube may correspond to the diameter or largest cross section of each corresponding tube insertion sleeve.

The one or more tubes may have a constant diameter along its/their length(s). The one or more tubes may be flexible and may comprise or consist of a plastic or polymer material, such as PET, PE, or PP. The one or more tubes may be tubular and may be cylindrical.

The tip part may comprise a nozzle. The nozzle may be positioned at or in the distal front wall. The nozzle may be integrally formed and in one piece with the distal front wall. The nozzle may generally be suitable for ejection of both gas and liquid. The nozzle outlet may generally be for ejection of both gas and liquid. The nozzle may be an outlet for one or more of the tube insertion sleeves and/or tubes.

The tip part, in particular the one or more tubes, may be connected to or be connectable to one or more fluid sources. The fluid provided from the fluid sources may be liquid and/or air or gas. The liquid may be water. The gas may be carbon dioxide. Ejection of liquid from or a liquid jet ejected or sprayed from the nozzle may be used for flushing with liquid and thereby cleaning at least part of the front surface of the camera window. Ejected gas may be used for cleaning remaining liquid on the camera window off after flushing with liquid. The ejected gas may also be used for expanding a body volume. The gas may also be used for accelerating or otherwise affecting the liquid flow and/or the liquid flushing process.

The tube insertion sleeve may be tubular. The tube insertion sleeve may be a cylindrical shell. The tube insertion sleeve may have a circular cross-section, potentially along an entire length of the tube insertion sleeve. The tube insertion sleeve may have circular end surfaces at its proximal end and/or distal end. The interior surface of the tube insertion sleeve may be complementary to an exterior surface of a tube to be inserted. The circumferential housing wall be annular.

The tip parts according to this disclosure may make it possible to reduce external dimensions of the tip parts and may reduce costs and time in manufacture.

The tip of the disposable insertion endoscope may be a distal tip of the disposable insertion endoscope.

The tip part may further comprise a bending section having a distal end segment, the distal end of the bending section and the proximal open end of the housing potentially being adjoined to each other.

The tip part may further comprise a camera window positioned in or forming part of the distal front wall.

The camera assembly may further comprise a vision sensor, a lens stack, and a printed circuit board (PCB).

In the context of the present disclosure, a sleeve is any component which allows insertion of another component into it.

The exterior housing may comprise a first material, which may be a first polymer material. The exterior housing may be an outer most wall of the tip part. The exterior housing may be cup-shaped, the cup being formed by the distal front wall and the circumferential wall. The exterior housing may fluid seal the interior spacing. The first material may be a fluid tight material.

The circumferential housing wall may have a cylindrical or circular-cylindrical outer and/or inner surface. The circumferential housing wall may comprise or be a circumferentially extending cylindrical wall.

The circumferential housing wall may extend in a direction distally-to-proximally. The distal front wall may extend in a transverse direction, the transverse direction being transverse to the distally-to-proximally direction.

The distal front wall may be positioned oppositely from the proximal end of the housing. The distal front wall may be at least partly coinciding with a distal end of the tip part.

Additionally or alternatively, the camera assembly may comprise a casing potentially in the form of a lens barrel, positioned between a first light source and a vision sensor of the camera assembly, the casing potentially including a light shield configured to substantially prevent light from passing through the casing. The light shield may be provided in the form of a light shielding layer provided on the casing. The light shielding layer may be provided by an adhesive, potentially hardened glue. The glue may be opaque, potentially black. The light shielding layer may be provided around the lens stack holder. The camera window may be a transparent part in or of the exterior housing enabling light to enter into the tip part to be received by the image sensor.

The camera window may comprise a second material, which may be a second polymer material, and which may be different from said first polymer material of the exterior housing. The second material may be a fluid tight material. The camera window and the exterior housing may be integrally molded in one piece by a multi-component molding process. A front surface of the camera window may be in the same plane as a front surface of the exterior housing.

The first polymer material may include or consist of one or several polymers and/or further materials. One or more of said polymers may be plastic or thermoplastic polymers. Said first polymer material and a potential second polymer material (see below) may be selected from thermoplastic materials, thermoset materials, and elastomers. The second material may comprise or consist of a transparent material and/or may include or consist of several polymers and/or further materials. Said first polymer material and/or said second polymer material may be fiber-reinforced. The first material may be opaque at least in a set condition. Said first polymer material may also be selected for other properties, such as good adhesion to sealant materials and adhesives. Thus, the set said first polymer material may have better adhesion properties to glue than the second polymer material.

A first window part and a second window part of the camera window may be molded as one single piece of a second polymer material.

The first material may be opaque. This may allow the introduction of shading parts inter alia reducing stray light and glare into the vision receptor.

The first material may have better adhesion properties to glue than the second material. This may allow the circumferential housing wall to adhere efficiently to a sealing glue for sealing the interior spacing, and for an exterior sleeve or an outer sheath of the insertion tube of the endoscope to be securely adhered to the exterior or the interior of the circumferential housing wall.

The second material may be a thermoplastic material. This may allow the exterior housing to be produced in an efficient manner, such as by injection molding.

The vision sensor may be a camera sensor of a camera which may form part of the camera assembly.

The term “integrally formed in one piece” as used herein may involve that two or more parts are integrally molded in one piece with each other, potentially in a multi-component molding process as disclosed herein.

The circumferential housing wall may be a side wall and/or may have a substantially cylindrical shape. The distal front wall and camera window may be integrally formed or molded in one piece. The distal front wall and the circumferential housing wall may form a liquid-tight (except for any potential inlets, outlets, and openings) barrier or border between an exterior of the tip part or the environment and the interior spacing of the tip part. The exterior housing may also accommodate at least part of a working channel for supplying fluid to a working channel opening in the distal front wall.

By integrally forming the circumferential housing wall and distal front wall, a sealed tip part may be provided. Additionally, assembly of the tip part may be made simpler as fewer parts are required. Similarly by integrally forming the circumferential tube sleeve wall and the distal front wall, a sealed tube sleeve may be provided.

Additionally or alternatively, the exterior housing may essentially consist of the same material as the window, such as a transparent material.